title: Dissolution criticality in developing solid oral formulations: from inception to perception.
abstract: Currently, dissolution testing has become a vital tool for accessing product performance, especially in the hierarchy of solid oral dosage forms. With advances in complicated, expensive, and sophisticated analytical instruments, characterization of formulations has become easier, but simple dissolution assembly is gradually gaining momentum from industrial environs as well as regulatory agencies. As such, simple dissolution testing involves many complexities which must be properly understood to reach correct conclusions. The appropriate selection of multiple parameters (e.g., apparatus, medium, agitation, etc.) involved in dissolution testing and understanding their impact on analysis require thorough subject knowledge. In the words of regulatory provisions, in vitro dissolution testing can become a surrogate for expensive and tedious bioequivalence studies in special cases (i.e., when a biowaiver is recommended). As a consequence, reduced human testing as well as lower product development cost ultimately benefit patients and society. Therefore, the dissolution science has recently become one of the keys for success for formulation scientists, especially generic manufacturers. While designing dissolution methodologies, generic manufacturers need to follow the respective regulatory guidelines at the product development stage; concomitant data are required for the approval process. This comprehensive review is an earnest attempt to acquaint readers with the history, contemporary practices, and relevant issues regarding dissolution which may become a guiding tool for overcoming challenges and opening better prospects in product development.
authors.affiliation: Pharmacy Department, Faculty of Technology and Engineering, The Maharaja Sayajirao University of Baroda, Kalabhavan, Vadodara-390001, Gujarat State, India.
authors.forename: Riddhish
authors.initials: R
authors.lastname: Patadia
authors.forename: Chintan
authors.initials: C
authors.lastname: Vora
authors.forename: Karan
authors.initials: K
authors.lastname: Mittal
authors.forename: Rajashree
authors.initials: R
authors.lastname: Mashru
mesh_terms: D000284:Administration, Oral; D000818:Animals; D004339:Drug Compounding / Q000295:instrumentation / Q000592:standards / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000737:chemistry / Q000592:standards; D011786:Quality Control; D012995:Solubility; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations